Safety and Efficacy of NovoLog vs. Humalog in Insulin Pumps in Children and Adolescents
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00097071 |
Recruitment Status
:
Completed
First Posted
: November 18, 2004
Last Update Posted
: December 22, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 1 | Drug: insulin lispro Drug: insulin aspart | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 299 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Insulin Aspart Versus Insulin Lispro in Insulin Pumps in Children and Adolescents With Type 1 Diabetes |
Study Start Date : | October 2004 |
Actual Primary Completion Date : | May 2006 |
Actual Study Completion Date : | May 2006 |

- HbA1c [ Time Frame: After 16 weeks treatment ]
- Measurements of glycaemic control, safety parameters including frequency of hypoglycaemia, laboratory tests, clinical evaluations and adverse events

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Ages Eligible for Study: | 3 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Type 1 Diabetes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097071

United States, Alabama | |
Novo Nordisk Investigational Site | |
Mobile, Alabama, United States, 36617 | |
Novo Nordisk Investigational Site | |
Montgomery, Alabama, United States, 36106 | |
United States, Arizona | |
Novo Nordisk Investigational Site | |
Phoenix, Arizona, United States, 85016 | |
United States, Arkansas | |
Novo Nordisk Investigational Site | |
Little Rock, Arkansas, United States, 72202 | |
United States, California | |
Novo Nordisk Investigational Site | |
Loma Linda, California, United States, 92354 | |
Novo Nordisk Investigational Site | |
Sacramento, California, United States, 95816 | |
Novo Nordisk Investigational Site | |
San Diego, California, United States, 92123 | |
United States, Colorado | |
Novo Nordisk Investigational Site | |
Denver, Colorado, United States, 80262 | |
Novo Nordisk Investigational Site | |
Englewood, Colorado, United States, 80110 | |
United States, Connecticut | |
Novo Nordisk Investigational Site | |
New Haven, Connecticut, United States, 06520 | |
United States, Florida | |
Novo Nordisk Investigational Site | |
Orlando, Florida, United States, 32806-1101 | |
Novo Nordisk Investigational Site | |
St. Petersburg, Florida, United States, 33701 | |
Novo Nordisk Investigational Site | |
Tallahassee, Florida, United States, 32308 | |
United States, Georgia | |
Novo Nordisk Investigational Site | |
Atlanta, Georgia, United States, 30318 | |
United States, Idaho | |
Novo Nordisk Investigational Site | |
Idaho Falls, Idaho, United States, 83404-7596 | |
United States, Indiana | |
Novo Nordisk Investigational Site | |
Indianapolis, Indiana, United States, 46202-2879 | |
United States, Iowa | |
Novo Nordisk Investigational Site | |
Iowa City, Iowa, United States, 52242 | |
United States, Kansas | |
Novo Nordisk Investigational Site | |
Topeka, Kansas, United States, 66606 | |
Novo Nordisk Investigational Site | |
Wichita, Kansas, United States, 67226 | |
United States, Louisiana | |
Novo Nordisk Investigational Site | |
Baton Rouge, Louisiana, United States, 70808 | |
United States, Maryland | |
Novo Nordisk Investigational Site | |
Baltimore, Maryland, United States, 21229 | |
Novo Nordisk Investigational Site | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Novo Nordisk Investigational Site | |
Boston, Massachusetts, United States, 02115 | |
Novo Nordisk Investigational Site | |
Boston, Massachusetts, United States, 02215 | |
Novo Nordisk Investigational Site | |
Springfield, Massachusetts, United States, 01107 | |
Novo Nordisk Investigational Site | |
Worcester, Massachusetts, United States, 01655 | |
United States, Michigan | |
Novo Nordisk Investigational Site | |
Detroit, Michigan, United States, 48202-2689 | |
United States, Minnesota | |
Novo Nordisk Investigational Site | |
Minneapolis, Minnesota, United States, 55416 | |
Novo Nordisk Investigational Site | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Novo Nordisk Investigational Site | |
Kansas City, Missouri, United States, 64108 | |
United States, Nebraska | |
Novo Nordisk Investigational Site | |
Omaha, Nebraska, United States, 68114 | |
Novo Nordisk Investigational Site | |
Omaha, Nebraska, United States, 68198-3020 | |
United States, New Jersey | |
Novo Nordisk Investigational Site | |
Hackensack, New Jersey, United States, 07601 | |
United States, New York | |
Novo Nordisk Investigational Site | |
Bronx, New York, United States, 10467 | |
Novo Nordisk Investigational Site | |
Brooklyn, New York, United States, 11219 | |
Novo Nordisk Investigational Site | |
Buffalo, New York, United States, 14222 | |
Novo Nordisk Investigational Site | |
Manhasset, New York, United States, 11030 | |
United States, North Carolina | |
Novo Nordisk Investigational Site | |
Asheville, North Carolina, United States, 28803 | |
Novo Nordisk Investigational Site | |
Chapel Hill, North Carolina, United States, 27599-7220 | |
United States, Ohio | |
Novo Nordisk Investigational Site | |
Columbus, Ohio, United States, 43203 | |
United States, Oklahoma | |
Novo Nordisk Investigational Site | |
Tulsa, Oklahoma, United States, 74136 | |
United States, Oregon | |
Novo Nordisk Investigational Site | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Novo Nordisk Investigational Site | |
Hershey, Pennsylvania, United States, 17033 | |
Novo Nordisk Investigational Site | |
Philadelphia, Pennsylvania, United States, 19107 | |
Novo Nordisk Investigational Site | |
Pittsburgh, Pennsylvania, United States, 15224 | |
United States, South Carolina | |
Novo Nordisk Investigational Site | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
Novo Nordisk Investigational Site | |
San Antonio, Texas, United States, 78229 | |
Novo Nordisk Investigational Site | |
San Antonio, Texas, United States, 78284 | |
United States, Virginia | |
Novo Nordisk Investigational Site | |
Norfolk, Virginia, United States, 23507 | |
United States, Washington | |
Novo Nordisk Investigational Site | |
Seattle, Washington, United States, 98105 | |
United States, West Virginia | |
Novo Nordisk Investigational Site | |
Charleston, West Virginia, United States, 25302 | |
United States, Wisconsin | |
Novo Nordisk Investigational Site | |
Milwaukee, Wisconsin, United States, 53226-0509 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00097071 History of Changes |
Other Study ID Numbers: |
ANA-2181 |
First Posted: | November 18, 2004 Key Record Dates |
Last Update Posted: | December 22, 2016 |
Last Verified: | December 2016 |
Keywords provided by Novo Nordisk A/S:
Diabetes, Type 1 |
Additional relevant MeSH terms:
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
Insulin, Globin Zinc Insulin Insulin Aspart Insulin Lispro Hypoglycemic Agents Physiological Effects of Drugs |